The following data is part of a premarket notification filed by Venis Di A. Vendrame with the FDA for Spectacle Frames.
| Device ID | K930435 |
| 510k Number | K930435 |
| Device Name: | SPECTACLE FRAMES |
| Classification | Spectacle, Magnifying |
| Applicant | VENIS DI A. VENDRAME VIA LEONARDO DA VINCI,4 31013 CODOGNE TREVISO, ITALY, IT |
| Contact | VENDRAME ALESSANDRO |
| Correspondent | VENDRAME ALESSANDRO VENIS DI A. VENDRAME VIA LEONARDO DA VINCI,4 31013 CODOGNE TREVISO, ITALY, IT |
| Product Code | HOI |
| CFR Regulation Number | 886.5840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-26 |
| Decision Date | 1993-09-20 |